Lake Region's steerable quidewires are intended for use in anqiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The attachment of the guidewire extension to the Lake Region Steerable quidewire creates a quidewire that can be used to exchange a catheter without removing the guidewire from the vessel. When the exchange is complete, the quidewire extension can be detached and the original quidewire can aqain be used in a conventional manner.

Device Description

The quidewire is a steerable PTFE coated stainless steel core wire; the distal portion may be either a 30 cm long stainless steel outer coil with a 2 cm long platinum inner coil to provide radiopacity, or a 30 cm long platinum coil for radiopacity; the tip may be either a straight, shapable configuration or a preshaped J The quidewires are coated with MDX configuration. The quidewires are bound by the following (silicone). parameters:

Outside Diameters: . 014" - . 018" 175 cm - 300 cm Lengths: Straight, Shapable and J Tips: Flexibility: Floppy to Support

The quidewire extension is a PTFE coated stainless steel wire with a connector at the distal end and is bound by the following parameters:

Outside Diameter: .014" - .018" Length: 145 cm

The alignment tool is a slit rubber or silicone cylinder which assists in the placement of the quidewire pin into the extension connector.

AI/ML Overview

The provided K970376 document describes a 510(k) premarket notification for guidewires and accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with specific acceptance criteria directly tied to clinical performance metrics like accuracy, sensitivity, or specificity.

Therefore, the requested information elements related to AI performance, human-in-the-loop studies, multi-reader multi-case studies, and general performance metrics for a diagnostic or AI-driven medical device are not applicable to this submission. This is a submission for a physical medical device (guidewire) where the "acceptance criteria" are based on physical, mechanical, and biocompatibility testing to ensure its safety and effectiveness are equivalent to existing devices.

Here's the breakdown of the information that is applicable based on the provided document:

1. Table of Acceptance Criteria (from physical/mechanical and biocompatibility testing) and Reported Device Performance

For the guidewires, the acceptance criteria are implicitly that the test results fall "within prescribed specification limits" and for biocompatibility, that the tests show no adverse effects. The specific numerical specifications are not provided, only the qualitative results.

Acceptance Criterion (Test Performed)	Reported Device Performance
Dimensional Measurement	All test results were within prescribed specification limits.
Distal Tip Flexibility	All test results were within prescribed specification limits.
Torsional Integrity	All test results were within prescribed specification limits.
Coating Durability	All test results were within prescribed specification limits.
Rotational Control	All test results were within prescribed specification limits.
Guidewire Pull Test	All test results were within prescribed specification limits.
Three Point Bend	All test results were within prescribed specification limits.
Extension Joint Coupling	All test results were within prescribed specification limits.
Catheter/Extension Joint Interface	All test results were within prescribed specification limits.
Extension Joint Integrity	All test results were within prescribed specification limits.
Acute Systemic Toxicity	No signs or symptoms of Systemic Toxicity were observed for any of the samples.
Cytotoxicity	The sampled passed per current USP.
Hemolysis	The samples did not produce hemolysis.
Intracutaneous Test	For all samples, skin reactions were not significant.
Physico-Chemical	The samples passed per current USP.
Thromboresistance	The samples were not considered thrombogenic.
Chemical Analyses	The samples meet specifications.
Pyrogen test	The products did not produce a pyrogenic response.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Physical/Mechanical Tests: Twenty (20) samples were selected for each product group.
Data Provenance: The tests were performed by Lake Region Manufacturing, Inc. (LRM). The location and exact time of the tests are not specified beyond the submission date (April 1997). This appears to be prospective testing conducted for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in the context of expert consensus is for diagnostic or interpretive devices. For this physical device, the "ground truth" for each test is the objective measurement against established engineering specifications and recognized biocompatibility standards (e.g., USP).

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of interpretations. The tests have objective outcomes (e.g., pass/fail against a specification).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device or a diagnostic device involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical, non-algorithmic device.

7. The Type of Ground Truth Used

For Physical/Mechanical Tests: Established engineering design specifications (mentioned as "design criteria" and "prescribed specification limits").
For Biocompatibility Tests: Recognized industry standards and guidance, specifically the FDA's DRAFT "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993, and current USP (United States Pharmacopeia) standards.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The "training set" for the manufacturing process would be the historical data and experience from the predicate device (previously offered by Baxter).

9. How the Ground Truth for the Training Set was Established

Not applicable for the reason above. The "ground truth" for the manufacturing process is the successful production of functional guidewires meeting specifications, based on established quality systems and processes, and equivalence to the predicate device.

Summary

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K970376

SECTION 2.0 - SUMMARY & CERTIFICATION

JUN - 6 1997

General Information 2.1
Company name, Address, and Telephone Number 2.1.1

Lake Region Manufacturing, Inc. (LRM) 340 Lake Hazeltine Drive Chaska, Mn 55318

Fax: 612/448-3441 612/448-5111 Telephone:

Device Trade Name/Proprietary Name 2.1.2
produce guidewires on an OEM basis for other LRM manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission.
Device Common Names/Unusual Names, Classification Names 2.1.3
These devices are commonly known as coronary catheter guidewires and accessories.
LRM Establishment Registration Number: 2126666 2.1.4
2.1.5 Classification of Devices

Catheter guidewires have been classified as Class II be the Circulatory Systems Devices Panel (reference 21 CFR 870.1330).

2.1.6 Applicability of Performance Standards
determined that no mandatory performance LRM has standards have been established for these devices under Section 514 of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act or by any subsequent requlatory action.

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Labels, Labeling, and Advertising 2.2

LRM produces cardiovascular and vascular guidewires on an OEM for other manufacturers, kit assemblers, and and basis distributors. Changes to the customer controlled labels, labeling, or promotional material are at their discretion, including the resolution of any resulting regulatory obligations.

A small fraction of the total production bears LRM controlled labels and labeling.

2.3 Summary of Safety and Effectiveness
This summary is being provided included in the Premarket Notification submission in lieu of a statement of availability.
Device Description 2.4
2.4.1 Description of Guidewires

Outside Diameters: . 014" - . 018" 175 cm - 300 cm Lengths: Straight, Shapable and J Tips: Flexibility: Floppy to Support

2.4.2 Description of the Guidewire Extension and Alignment Tool
The quidewire extension is a PTFE coated stainless steel wire with a connector at the distal end and is bound by the following parameters:

Outside Diameter: .014" - .018" Length: 145 cm

The alignment tool is a slit rubber or silicone cylinder which assists in the placement of the quidewire pin into the extension connector.

2.4.3 Engineering Specifications
The design specifications are the same for the products offered by LRM as when they were offered by Baxter. The finished devices must meet the same design criteria. Additional diameter offerings in the .016" and .018" range have been added to the product options. Section 2.5 contains comparative data.

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Substantial Equivalence Data 2.5

Background Information 2.5.1

In order to demonstrate equivalence of the products, LRM performed physical/mechanical testing to support this submission.

2.5.2 Test Data
Within each product group, there were twenty (20) samples selected. The following tests were performed:
Dimensional Measurement: Micrometer measurement of 2.5.2.1 the outside diameter of the guidewire at multiple body points.
Assess the flexibility of Distal Tip Flexibility: 2.5.2.2 a distal tip.
torqueable Assess the Torsional Integrity: 2.5.2.3 strength of a quidewire.
Durability: Measures the number of 2.5.2.4 Coating controlled abrasion strokes necessary to cause deformation or removal of PTFE coating.
Rotational Control: Assess guidewire rotational 2.5.2.5 control (clockwise or counter clockwise) to allow placement of the distal tip at a desired location in a 360°circle when controlled from the proximal end of the guidewire.
Guidewire Pull Test: Measures the strength of the 2.5.2.6 joints of the guidewire.
Measures stiffness/flexibility 2.5.2.7 Three Point Bend: of quidewire body.
Assess ease of joint 2.5.2.8 Extension Joint Coupling: connection.
Catheter/Extension Joint Interface: Confirm 2.5.2.9 clearance and smooth transition of extension joint relative to the catheter.
Extension Joint Integrity: extended Assess 2.5.2.10 quidewire joint functionality.
All test results were within prescribed specification RESULTS : limits.

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2.6 Qualification and Test Data

Material/Product/Process Qualification 2.6.1

LRM has formal quality systems in place to assure that each of the products manufactured remain equivalent to the predicate products and that there will be no adverse affects on the safe and effective use of the products. the quality systems include Engineering Change Order Review, Material Qualification, Product Qualification, and Process Qualification. These controls are applies to each product size/group.

2.6.2 Biocompatibility Testing

biocompatibility LRM has adapted the testing recommendations in the FDA's DRAFT "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993.

The following table lists the tests that were performed and the test results.

TEST PERFORMED	TEST RESULTS
Acute Systemic Toxicity	No signs or symptoms of SystemicToxicity were observed for any ofthe samples
Cytotoxicity	The sampled passed per current USP
Hemolysis	The samples did not producehemolysis
Intracutaneous Test	For all samples, skin reactionswere not significant
Physico-Chemical	The samples passed per current USP
Thromboresistance	The samples were not consideredthrombogenic
Chemical Analyses	The samples meet specifications
Pyrogen test	The products did not produce apyrogenic response

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2.7 Packaging and Sterilization Information

LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is limited direct distribution by LRM. A portion of the production is private label, single packaged to customer specifications, a portion of that product is provided sterile to the customer.

The single packaged guidewire and extension wire are placed in a polyethylene dispensers and then into a Tyvek®/poly pouch. The product may be packaged as five (5) pouches in a shelf carton (five pack), which is a typical packaging configuration.

There will be no changes to the sterilization process for the portion of the product shipped sterile to the customer. for product that is shipped bulk, the packaging design and sterilization process parameters are the customer's responsibility. ¯ LRM will not recommend that its customers modify the packaging or sterilization procedures as a result of this submission.

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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 1997

Ms. Kim Aves Lake Region Manufacturing, Inc. ---------------------------------------------------------------------------------------340 Lake Hazeltine Drive Chaska, Minnesota 55318

Re: %K970376 PTCA Guidewire Requlatory Class: II (two) Product Code: 74 DQX Dated: April 3, 1997 Received: April 4, 1997

Dear Ms. Aves:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Kim Eves

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. ( allahan, Ph.I Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): Unknown

Steerable Guidewire and Extension Wire Device Name:

Indications for Use:

Lake Region's steerable quidewires are intended for use in anqiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ta A- R

(Division Sign-Off Division of Cardiovascular, Respirato and Neurological Devices 510(k) Number

Prescription Use x (Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.